Local Anaesthetic Infusion For Laparoscopic Hysterectomy

Local Anaesthetic Infusion For Laparoscopic Hysterectomy: A Randomised Controlled Trial

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01291147

Enrollment

Registered

2011-02-08

Start date

2011-02-28

Completion date

2013-02-28

Last updated

2013-11-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Postoperative Pain

Keywords

pain, anaesthetic

Brief summary

More hysterectomies are performed laparoscopically either as a total laparoscopic hysterectomy or as a laparoscopically assisted vaginal hysterectomy. The advantages of laparoscopic surgery include quicker hospital discharge, a shorter convalescence and cost effectiveness when compared to open procedures. Laparoscopic hysterectomies (both total and vaginally assisted) can lead to discomfort which may lead to a delay in discharge from hospital. Continuous infusions of local anaesthetic agents given post operatively to the site of operation have the been subject of trials for several operative procedures. To date however there have not been any properly controlled studies evaluating whether there are benefits of giving a local anaesthetic infusion for 48 hours into the pelvis following a total or vaginally assisted laparoscopic hysterectomy. The investigators therefore propose to investigate whether giving a local anaesthetic infusion in this fashion decreases the amount of rescue and patient controlled analgesia needed, and length of hospital stay. In order to do this the investigators wish to conduct a randomised placebo controlled double blind trial.

Interventions

DRUGLevobupivicaine

levobupivicaine 0.5% continous infusion for 48 hours

DRUG0.9% Saline

0.9% saline continous infusion for 48 hours

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

TRIPLE (Subject, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

FEMALE

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

All women undergoing a total laparoscopic or laparoscopically assisted vaginal hysterectomy

Exclusion criteria

Women undergoing surgery for cancer, or are known to be allergic to local anaesthetic agents.

Design outcomes

Primary

Measure	Time frame
• Need for 'rescue' analgesia	48 hours

Secondary

Measure	Time frame
• Pain intensity	48 hours
Side effects from rescue analgesia	48 hours
Amount of patient controlled analgesia needed	48 hours
Hospital length of stay	48 hours
Patient satisfaction with pain relief	48 hours

Countries

United Kingdom

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026